Trials / Completed
CompletedNCT00061633
Phase 2 Trial of TD 6424 (Telavancin) Versus Standard Therapy for Complicated Gram Positive Skin and Skin Structure Infections (Gram Positive cSSSI)
A Phase 2, Randomized, Double-Blind, Multinational Trial of Intravenous Telavancin Versus Standard Therapy for Treatment of Complicated Gram Positive Skin and Skin Structure Infections (Gram Positive cSSSI)
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 169 (actual)
- Sponsor
- Cumberland Pharmaceuticals · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
Serious infections caused by resistant bacteria are becoming more of a medical problem throughout the world. One of the ways to deal with this problem is to develop new drugs that can control these bacteria. This study will measure how well TD-6424 (Telavancin) can control infections and whether this drug can be safely given to patients.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Telavancin | Telavancin 7.5 mg/kg/day IV (intravenously) for up to 14 days |
| DRUG | Vancomycin or antistaphylococcal penicillin | Vancomycin 1 Gram IV (intravenously) every 12 hrs or nafcillin 2 Grams, oxacillin 2 Grams, or (in South Africa) cloxacillin 0.5 - 1 Gram, IV (intravenously) every 6 hrs for up to 14 days. |
Timeline
- Start date
- 2003-06-01
- Primary completion
- 2004-01-01
- Completion
- 2004-01-01
- First posted
- 2003-06-02
- Last updated
- 2019-01-16
- Results posted
- 2010-01-11
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT00061633. Inclusion in this directory is not an endorsement.